Procedure in compliance with Good Clinical Practice. Study conducted according to acceptable scientific conditions; number of volunteers, applied dose, observation time and observed parameters are acceptable. Substance identification: commercial name available from industrial for code name. Substance analytical certificate not available in the report

Justification for type of information:

A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.

Procedure in compliance with Good Clinical Practice. Study conducted according to acceptable scientific conditions; number of volunteers, applied dose, observation time and observed parameters are acceptable. Substance identification: commercial name available from industrial for code name. Substance analytical certificate not available in the report

Justification for type of information:

A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.

Reason / purpose:

read-across source

Reason / purpose:

reference to same study

Type of study / information:

Determination of Phototoxicity and Primary Irritancy.

Qualifier:

no guideline required

Principles of method if other than guideline:

A preliminary Phase I study was conducted to determine the Minimum Erythemogenic Dose (MED) for each member of a group of thirty panelists when the skin of each is irradiated by UV-B light.The aim of the phase II study was the determination of Phototoxicity and Primary Irritancy of MRD-88-295 in Human skin.The procedure required the concurrent application of the test materials on corresponding heterolateral sites of the upper arms of each panelist.On each arm, 4 test sites were used a 5th site serving as a control (no test material applied).Day 1: each testing site had 0.3 mL of a 50% w/w MRD-88-295 solution applied to it and held in contact with the skin for 24 hours under a semi-occlusive dressing.Day 2: After 24 hours, participants returned and had 0.3 mL of a neat solution of MRD-88-295 or water (if control) was applied to the same sites, which was removed after 10 minutes. The right arm was exposed to 15 min UV-A followed by 1 MED of UV-B (phototoxicity) and the left arm was not (primary irritant study), both arms were examined for irritation. Participants returned at 24, 48 and 72 hours for an examination for dermal irritation.

CLINICAL HISTORYA past/present medical history and a brief physical was performed and obtained for each individual. Candidates were excluded for any one of the following reasons: systemic illness which might have contra-indicated participation in another sensitization study within the past 10 weeks.

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION- Number of subjects with positive reactions: 0- Number of subjects with negative reactions: 30- Number of subjects with equivocal reactions: 0- Number of subjects with irritating reactions: 0

Table 7.10.4/2: Intensity of responses observed on irradiated and control sites (upper Right Arm)

Sites treated with MRD-88-295

Sites NOT Treated with MRD-88-295

Subject number

M (1)

T (2)

W (3)

Th (4)

F (5)

M (1)

T (2)

W (3)

Th (4)

F (5)

1

0

0

1

1

0

0

0

1

1

0

2

0

0

1

1

1

0

0

1

1

1

3

0

0

1

1

0

0

0

1

1

0

4

0

0

1

1

1

0

0

1

1

1

5

0

0

1

1

1

0

0

1

1

1

6

0

0

1

1

0

0

0

1

1

0

7

0

0

1

1

0

0

0

1

1

0

8

0

0

1

1

0

0

0

1

1

0

9

0

0

1

1

1

0

0

1

1

1

10

0

0

1

1

0

0

0

1

1

0

11

0

0

1

1

0

0

0

1

1

0

12

0

0

1

1

1

0

0

1

1

1

13

0

0

1

1

1

0

0

1

1

1

14

0

0

1

1

1

0

0

1

1

1

15

0

0

1

1

0

0

0

1

1

0

16

0

0

1

1

0

0

0

1

1

0

17

0

0

1

1

0

0

0

1

1

0

18

0

0

1

1

0

0

0

1

1

0

19

0

0

1

1

0

0

0

1

1

0

20

0

0

1

1

0

0

0

1

1

0

21

0

0

1

1

0

0

0

1

1

0

22

0

0

1

1

0

0

0

1

1

0

23

0

0

1

1

0

0

0

1

1

0

24

0

0

1

1

0

0

0

1

1

0

25

0

0

1

1

1

0

0

1

1

1

26

0

0

1

1

0

0

0

1

1

0

27

0

0

1

1

0

0

0

1

1

0

28

0

0

1

1

0

0

0

1

1

0

29

0

0

1

1

1

0

0

1

1

1

30

0

0

1

1

1

0

0

1

1

1

(1) Baseline - Examination before application of test material.

(2) Results of examination after 24 hours of contact with either the test material or control.

(3) Results of examination 24 hours post-irradiation.

(4) Results of examination 48 hours post-irradiation.

(5) Results of examination 72 hours post-irradiation.

Conclusions:

Under the test conditions, MRD-88-295 did not elicit any effects which could be considered as characteristic of a photoxic propensity or a primary irritant.

Executive summary:

This study included three phases which evaluated different propensities of the MRD-88-295 test substance as the first phase was only a preliminary test condition study.

The phase II study was performed in order to determine the Phototoxicity and the Primary irritancy propensities of MRD-88-295 in human skin.

A preliminary Phase I study was conducted to determine the Minimum Erythemogenic Dose (MED) for each member of a group of thirty panelists when the skin is irradiated by UV-B light. The least duration of UV-B exposure which produced erythema of Grade 1 or greater was selected as the MED value for each panelist. One volunteer was dropped out at the end of the phase II of the study.

The Phase II study was performed with a panel of 30 volunteers. The test substance was diluted at 50% w/w in petrolatum and 0.3 g of solution were applied to skin of volunteers under semi-occlusive patches for a period of 24 hours. The control site was also covered with a similar semi-occlusive bandage without test substance. After exposure, skin examinations were conducted. After first exposure, participants received 0.3 g of undiluted MRD-88-295 (or water for negative control site) on the same sites, which was removed after 10 minutes. Then, for the phototoxicity determination, the right arm was exposed to 15 min UV-A followed by 1 MED of UV-B. The left arm was not exposed to UV to determine the primary irritancy. Both arms were examined for dermal irritation at 24, 48 and 72 hours after exposure.Skin reaction was not observed in any subjects.

Under the test conditions, MRD-88-295 did not elicit any effects which could be construed as characteristic of a phototoxic propensity or a primary irritant.

Data source

Reference

Materials and methods

Type of study / information:

Determination of Phototoxicity and Primary Irritancy.

Test guideline

Qualifier:

no guideline required

Principles of method if other than guideline:

A preliminary Phase I study was conducted to determine the Minimum Erythemogenic Dose (MED) for each member of a group of thirty panelists when the skin of each is irradiated by UV-B light.The aim of the phase II study was the determination of Phototoxicity and Primary Irritancy of MRD-88-295 in Human skin.The procedure required the concurrent application of the test materials on corresponding heterolateral sites of the upper arms of each panelist.On each arm, 4 test sites were used a 5th site serving as a control (no test material applied).Day 1: each testing site had 0.3 mL of a 50% w/w MRD-88-295 solution applied to it and held in contact with the skin for 24 hours under a semi-occlusive dressing.Day 2: After 24 hours, participants returned and had 0.3 mL of a neat solution of MRD-88-295 or water (if control) was applied to the same sites, which was removed after 10 minutes. The right arm was exposed to 15 min UV-A followed by 1 MED of UV-B (phototoxicity) and the left arm was not (primary irritant study), both arms were examined for irritation. Participants returned at 24, 48 and 72 hours for an examination for dermal irritation.

Method

CLINICAL HISTORYA past/present medical history and a brief physical was performed and obtained for each individual. Candidates were excluded for any one of the following reasons: systemic illness which might have contra-indicated participation in another sensitization study within the past 10 weeks.

Results and discussion

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION- Number of subjects with positive reactions: 0- Number of subjects with negative reactions: 30- Number of subjects with equivocal reactions: 0- Number of subjects with irritating reactions: 0

Any other information on results incl. tables

Table 7.10.4/2: Intensity of responses observed on irradiated and control sites (upper Right Arm)

Sites treated with MRD-88-295

Sites NOT Treated with MRD-88-295

Subject number

M (1)

T (2)

W (3)

Th (4)

F (5)

M (1)

T (2)

W (3)

Th (4)

F (5)

1

0

0

1

1

0

0

0

1

1

0

2

0

0

1

1

1

0

0

1

1

1

3

0

0

1

1

0

0

0

1

1

0

4

0

0

1

1

1

0

0

1

1

1

5

0

0

1

1

1

0

0

1

1

1

6

0

0

1

1

0

0

0

1

1

0

7

0

0

1

1

0

0

0

1

1

0

8

0

0

1

1

0

0

0

1

1

0

9

0

0

1

1

1

0

0

1

1

1

10

0

0

1

1

0

0

0

1

1

0

11

0

0

1

1

0

0

0

1

1

0

12

0

0

1

1

1

0

0

1

1

1

13

0

0

1

1

1

0

0

1

1

1

14

0

0

1

1

1

0

0

1

1

1

15

0

0

1

1

0

0

0

1

1

0

16

0

0

1

1

0

0

0

1

1

0

17

0

0

1

1

0

0

0

1

1

0

18

0

0

1

1

0

0

0

1

1

0

19

0

0

1

1

0

0

0

1

1

0

20

0

0

1

1

0

0

0

1

1

0

21

0

0

1

1

0

0

0

1

1

0

22

0

0

1

1

0

0

0

1

1

0

23

0

0

1

1

0

0

0

1

1

0

24

0

0

1

1

0

0

0

1

1

0

25

0

0

1

1

1

0

0

1

1

1

26

0

0

1

1

0

0

0

1

1

0

27

0

0

1

1

0

0

0

1

1

0

28

0

0

1

1

0

0

0

1

1

0

29

0

0

1

1

1

0

0

1

1

1

30

0

0

1

1

1

0

0

1

1

1

(1) Baseline - Examination before application of test material.

(2) Results of examination after 24 hours of contact with either the test material or control.

(3) Results of examination 24 hours post-irradiation.

(4) Results of examination 48 hours post-irradiation.

(5) Results of examination 72 hours post-irradiation.

Applicant's summary and conclusion

Conclusions:

Under the test conditions, MRD-88-295 did not elicit any effects which could be considered as characteristic of a photoxic propensity or a primary irritant.

Executive summary:

This study included three phases which evaluated different propensities of the MRD-88-295 test substance as the first phase was only a preliminary test condition study.

The phase II study was performed in order to determine the Phototoxicity and the Primary irritancy propensities of MRD-88-295 in human skin.

A preliminary Phase I study was conducted to determine the Minimum Erythemogenic Dose (MED) for each member of a group of thirty panelists when the skin is irradiated by UV-B light. The least duration of UV-B exposure which produced erythema of Grade 1 or greater was selected as the MED value for each panelist. One volunteer was dropped out at the end of the phase II of the study.

The Phase II study was performed with a panel of 30 volunteers. The test substance was diluted at 50% w/w in petrolatum and 0.3 g of solution were applied to skin of volunteers under semi-occlusive patches for a period of 24 hours. The control site was also covered with a similar semi-occlusive bandage without test substance. After exposure, skin examinations were conducted. After first exposure, participants received 0.3 g of undiluted MRD-88-295 (or water for negative control site) on the same sites, which was removed after 10 minutes. Then, for the phototoxicity determination, the right arm was exposed to 15 min UV-A followed by 1 MED of UV-B. The left arm was not exposed to UV to determine the primary irritancy. Both arms were examined for dermal irritation at 24, 48 and 72 hours after exposure.Skin reaction was not observed in any subjects.

Under the test conditions, MRD-88-295 did not elicit any effects which could be construed as characteristic of a phototoxic propensity or a primary irritant.

Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.

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